BS EN ISO 16672:2021 – TC
$186.33
Tracked Changes. Ophthalmic implants. Ocular endotamponades
| Published By | Publication Date | Number of Pages |
| BSI | 2021 | 58 |
This document applies to ocular endotamponades (OE), a group of non-solid surgically invasive medical devices introduced into the vitreous cavity of the eye to flatten and position a detached retina onto the retinal pigment epithelium (RPE), or to tamponade the retina.
With regard to the safety and efficacy of OE, this document specifies requirements for their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product packaging, product labelling and the information supplied by the manufacturer.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 36 | National foreword |
| 38 | European foreword |
| 40 | Foreword |
| 41 | 1 Scope 2 Normative references 3 Terms and definitions |
| 43 | 4 Intended performance 5 Design attributes 5.1 General 5.2 Chemical description and contaminants |
| 44 | 5.3 Density 5.4 Gaseous expansion 5.5 Interfacial tension 5.6 Kinematic viscosity 5.7 Dynamic viscosity 5.8 Molecular mass distribution |
| 45 | 5.9 Particulates 5.10 Refractive index 5.11 Spectral transmittance 5.12 Surface tension 5.13 Vapour pressure 6 Design evaluation 6.1 General |
| 46 | 6.2 Evaluation of biological safety 6.2.1 General 6.2.2 Bacterial endotoxins test 6.2.3 Intraocular implantation test 6.2.4 Ethylene oxide |
| 47 | 6.3 Clinical investigation 7 Sterilization 8 Product stability 9 Integrity and performance of the delivery system |
| 48 | 10 Packaging 10.1 Protection from damage during storage and transport 10.2 Maintenance of sterility in transit 11 Information supplied by the manufacturer |
| 50 | Annex A (normative) Intraocular implantation test |
| 51 | Annex B (informative) Clinical investigation |
| 54 | Annex C (informative) Method for quantifying incompletely fluorinated contaminants in perfluorocarbon liquids |
| 56 | Bibliography |
Related products
-
BS EN ISO 16484-5:2022 – TC:2023 Edition
Tracked Changes. Building automation and control systems (BACS) – Data communication protocol Published By Publication…
-
BSI PD CEN/TR 17868:2022
Intelligent transport systems. EU-ICIP. ITS standards deliverables (2022) Published By Publication Date Number of Pages…
-
BS EN ISO 17672:2016 – TC:2020 Edition
Tracked Changes. Brazing. Filler metals Published By Publication Date Number of Pages BSI 2020 72
